The South African Health Products Regulatory Authority (SAHPRA) has granted Section 21 authorisation for the emergency importation of Dollvet foot-and-mouth disease vaccines, marking a crucial step in protecting the country’s livestock industry from the highly contagious viral outbreak.

SAHPRA confirmed that it has approved the importation with conditions and is currently reviewing an additional application for the same vaccine. The move comes as authorities work to contain FMD outbreaks that pose severe threats to cattle, pigs, sheep and goats across the country.

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“The health of our livestock is critical to South Africa’s food security, economic stability and the livelihoods of our farmers,” said Dr Boitumelo Semete-Makokotlela, SAHPRA’s Chief Executive Officer. “By granting Section 21 authorisation for the importation of FMD vaccines, SAHPRA is ensuring that veterinarians and farmers have timely access to safe, effective and scientifically approved tools to protect animals against this highly contagious and devastating disease.”

Rapid Response Mechanism

The Section 21 pathway allows for controlled importation of medicines and vaccines not yet registered in South Africa under strict regulatory oversight. This emergency mechanism enables rapid response to urgent animal health crises while maintaining rigorous safety and efficacy standards. The authorisations are temporary and subject to ongoing review.

Coordinated Distribution Strategy

Distribution of the imported vaccines will be coordinated exclusively by the Department of Agriculture’s Animal Health division, which oversees national disease control measures. The department has emphasised that FMD remains a controlled disease and vaccination must only occur within officially approved programmes.

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Dr Bothle Modisane, Chief Director for Animal Health at the National Department of Agriculture, stressed the importance of regulated vaccination efforts. “Our collaboration with SAHPRA reflects the importance of partnerships in safeguarding animal health. The South African farming community can be assured that every vaccine authorised for use in the country undergoes careful evaluation for safety, efficacy, especially against locally circulating strains, and quality and we are optimistic that the disease will be contained.”

The rapid spread of FMD through direct animal contact, contaminated equipment, vehicles, clothing, feed and wildlife carriers has prompted strict movement restrictions and quarantines. Beyond immediate production losses, outbreaks threaten South Africa’s FMD-free status, which could trigger immediate export bans on livestock and related products, resulting in significant foreign revenue losses.

Strict Regulatory Controls

Authorities warn that unregulated vaccination outside approved programmes could mask infections, weaken surveillance systems and delay the country’s ability to regain FMD-free status under World Organisation for Animal Health standards.

All imported vaccines will undergo strict regulatory controls and quality assurance processes before reaching farms. SAHPRA has committed to maintaining transparency and will continue updating stakeholders on developments related to veterinary vaccine import authorisations for FMD control.